Medical needle removal and storage device

ABSTRACT

An apparatus for removing a needle from a needle holder, including a grasping unit for selectively grasping the needle; a receiving unit for receiving the needle holder, displaceably disposed relative to the grasping unit; a biasing member biasing the receiving unit in a first direction; and separating means for separating the entire needle from the needle holder. Preferably, the needle is heated to melt, soften, or otherwise weaken a material and/or adhesive connecting the needle with the needle holder. Preferably the heating is electrical heating, including completing an electrical circuit through the needle and passing current through the needle, and/or passing current through a heating element.

FIELD OF THE INVENTION

The present invention relates generally to a device for removing medicalneedles and storing the removed needles.

BACKGROUND OF THE INVENTION

After a needle, such as a hypodermic needle, or a pen needle has beenused for an injection, it is desirable to remove and store the needle ina safe container. A sharps container for storing needles, which is knownin the art, includes an inner box member and an outer housing member.The box and the housing each have an aperture that is dimensioned toreceive a hypodermic needle. The box and the housing are hingedlyconnected to each other so that in an open position the apertures of thebox and the housing overlap and the needle may be inserted through bothof the apertures to project into the box. After the needle has beeninserted into the apertures, the box and the housing are moved withrespect to each other, for example in a scissor motion, so that theneedle is clipped. After being clipped, the needle drops into the boxfor storage and subsequent disposal.

U.S. Pat. No. 6,545,242 to Butler discloses a device that, subsequent toinsertion of a portion of a needle, heats at least a portion of theneedle to approximately 1750° C., and then shears the needle, leaving aportion in the needle holder or hub. Similarly, U.S. Pat. No. 5,545,689to Piva discloses a device that melts a portion of a blade or needle andcuts the stump of the blade or needle, leaving a portion of the blade orneedle in the needle/blade holder or hub. Additionally, U.S. Pat. No.4,867,309 to Germain discloses a device that holds a needle and itsholder or hub by the needle stem, so that a user can twist the hub offof a syringe, or pull off the hub if the hub is friction-fitted on thesyringe.

With each of these devices, however, a portion of the needle remains inthe needle holder. Therefore, the potential for a needle-stick injurymay remain. Additionally, the needle holder must be disposed of asmedical waste, and cannot be recycled. Consequently, an improved medicalneedle removal device that removes the needle entirely is desirable.Storage of the removed needles is also desirable.

SUMMARY OF THE INVENTION

An aspect of the present invention is to provide a device for removingand storing medical needles.

The foregoing and/or other aspects of the present invention are achievedby providing an apparatus for removing a needle from a needle holder,including a grasping unit for selectively grasping the needle; areceiving unit for receiving the needle holder, displaceably disposedrelative to the grasping unit; a biasing member biasing the receivingunit in a first direction; and separating means for separating theentire needle from the needle holder.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a method of separating a needle from a needleholder, including receiving the needle holder in a receiving unit biasedin a first direction; displacing the receiving unit relative to agrasping unit in a second direction opposite to the first direction,thereby automatically causing the grasping unit to grasp the needle andactivating a separator for separating the needle from the needle holder;and maintaining the grasp of the needle until the separator separatesthe entire needle from the needle holder.

The foregoing and/or other aspects of the present invention are alsoachieved by providing an apparatus for removing a needle from a needleholder, including a grasping unit for selectively grasping the needle; areceiving unit for receiving the needle holder, displaceably disposedrelative to the grasping unit; a biasing member biasing the receivingunit in a first direction; a separator for separating the entire needlefrom the needle holder; and a storage unit for storing the separatedneedle.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a method of separating a needle adhered to and/ormolded in a needle holder, including heating the needle to melt, soften,or otherwise weaken a material and/or adhesive connecting the needlewith the needle holder; and separating the entire needle from the needleholder.

Additional and/or other aspects and advantages of the present inventionwill be set forth in part in the description that follows and, in part,will be apparent from the description, or may be learned by practice ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and/or other aspects and advantages of embodiments of theinvention will be more readily appreciated from the following detaileddescription, taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a cross-sectional schematic view of a needle removal andstorage device in accordance with an embodiment of the presentinvention;

FIG. 2 is a cross-sectional schematic view of the device of FIG. 1 inoperation;

FIG. 3 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 4 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 5 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 6 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 7 is a cross-sectional schematic view of the device of FIG. 6 inoperation;

FIG. 8 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 9 is a cross-sectional schematic view of the device of FIG. 8 inoperation;

FIG. 10 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 11 is a cross-sectional schematic view of the device of FIG. 10 inoperation;

FIG. 12 is a schematic view of a circuit of the device of FIG. 10;

FIG. 13 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 14 is a cross-sectional schematic view of the device of FIG. 13 inoperation;

FIG. 15 is a schematic view of a circuit of the device of FIG. 13;

FIG. 16 is a cross-sectional schematic view of a needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 17 is a cross-sectional schematic view of the device of FIG. 16 inoperation;

FIG. 18 is a perspective view of a bead-needle assembly in accordancewith an embodiment of the present invention;

FIGS. 19-21 are perspective views of alternative beads;

FIG. 22 is a carrier for the bead-needle assembly of FIG. 18;

FIGS. 23 and 24 are partial perspective views illustrating connection ofan injection pen adapter and the bead-needle assembly of FIG. 18;

FIG. 25 is a partial perspective view of a cutting unit;

FIG. 26 is a partial perspective view of a needle removal and storagedevice in accordance with another embodiment of the present invention;

FIGS. 27 and 28 are perspective views of opposing ends of a carrier andneedle removal and storage device in accordance with another embodimentof the present invention;

FIG. 29 is a perspective view of a carrier and needle removal andstorage device in accordance with another embodiment of the presentinvention;

FIG. 30 is a cross-sectional schematic view of a sharps container withneedle removal and storage devices in accordance with embodiments of thepresent invention disposed thereon;

FIG. 31 is a perspective view of a case including a needle removal andstorage device in accordance with an embodiment of the presentinvention;

FIG. 32 is a perspective view of a pen needle dispenser with a needleremoval and storage device in accordance with an embodiment of thepresent invention disposed thereon;

FIG. 33 is a perspective view of another pen needle dispenser with aneedle removal and storage device in accordance with an embodiment ofthe present invention disposed thereon; and

FIG. 34 is a perspective view of another pen needle dispenser with aneedle removal and storage device in accordance with an embodiment ofthe present invention disposed thereon.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Reference will now be made in detail to embodiments of the presentinvention, examples of which are illustrated in the accompanyingdrawings, wherein like reference numerals refer to the like elementsthroughout. The descriptions of these embodiments exemplify the presentinvention by referring to the drawings.

Descriptions of directions, such as upward, downward, axially, andradially are used herein for reference purposes, but are not limiting.Additionally, for brevity, the word “needle” is used herein to representa needle, a cannula, or a capillary used in a medical device. Typically,an adhesive is used to adhere a needle to a needle holder. For example,as shown in FIG. 1, a needle 10 is adhered to a needle holder or hub 20,forming a pen needle 30 for attachment to the end of a pen injectiondevice. The metal needle is held in the hub of the pen needle or syringeusing a commercially available adhesive (e.g., UV or heat curableepoxies). Alternatively, a needle may be embedded without an adhesive ina plastic needle holder during a molding process. Examples of materialsfor the needle holder include polyethylene and polypropylene.

FIGS. 1 and 2 are cross-sectional schematic views of a needle removaland storage device 100 in accordance with an embodiment of the presentinvention. The device 100 includes a grasping unit 104, a receiving unit108 displaceably disposed relative to the grasping unit 104, and abiasing unit 112. According to one embodiment, the biasing unit 112 is aspring 112. One skilled in the art will appreciate that other biasingunits maybe employed without departing from the scope of the presentinvention. The biasing unit 112 biases the receiving unit 108 in a firstdirection. In addition, the receiving unit 108 includes a wing 148 forlimiting displacement of the receiving unit 108 in the first direction.

The grasping unit 104 includes first and second forceps-like arms 116and 120, and a storage unit 124. The receiving unit 108 includes areceiving portion 128 for receiving the needle holder 20, and anactivating unit 132 for automatically causing the first and second arms116 and 120 to grasp the needle 10 upon displacement of the receivingunit 108 in a second direction opposite to the first direction.

According to one embodiment, the first and second arms 116 and 120 eachhave a tapered portion 136 and the activating unit 132 has acorresponding tapered portion 140 on an internal portion thereof.According to one embodiment, the activating unit 132 includes an annulardisk held between a pair of supporting arms 144 of the receiving unit108. The interior of the annular disk 132 includes the tapered portion140. The activating unit 132 may be made of plastic or metal, such asstainless steel. According to another embodiment, the activating unit132 and the receiving unit 108 are integrally formed as a unitaryconstruction.

The device 100 also includes separating means 150 for separating theentire needle 10 from the needle holder 20. In the embodiment of FIGS. 1and 2, the separating means 150 includes the electrical circuit 152completed by the needle 10. Electrical circuit 152 includes first andsecond electrical contacts 156 and 160 disposed on the first arm 116. Inaddition, the electrical circuit 152 includes a power source 164schematically represented as an ideal voltage source or ideal battery164.

Although the power source 164 is not depicted as being disposed oneither the grasping unit 104 or the receiving unit 108, it will beunderstood by one skilled in the art that the power source 164 may bedisposed on the grasping unit 104 or the receiving unit 108 withoutdeparting from the scope of the present invention. Additionally,according to one embodiment, the power source 164 may be a stand-aloneunit. Further, although the power source 164 may be a portable DC powersource such as a battery (for example, AA, 9V, or rechargeable battery),one skilled in the art will appreciate that other power sources may alsobe employed, such as an AC wall receptacle or the electrical system ofan automobile (for example, an ambulance) without departing from thescope of the present invention.

Referring to FIGS. 1 and 2, to use the device 100, the user places theneedle holder 20 of the pen needle 30 into the receiving portion 128 ofthe receiving unit 108 and then presses downwardly (second direction) onthe receiving unit 108. As the user presses down the receiving unit 108,compressing the biasing unit 112, the tapered portion 140 of theactivating unit 132 slidingly contacts the tapered portions 136 of thefirst and second arms 116 and 120, forcing the ends of the arms 116 and120 together, away from their initial spaced-apart positions, to graspthe needle 10. The downward (second direction) motion of the receivingunit 108 continues until the tapered portion 140 wedges against thetapered portions 136 and the first and second arms 116 and 120 firmlygrasp the needle 10. This wedging action effectively temporarily locksthe receiving unit 108 relative to the grasping unit 104.

In addition, as the first and second arms 116 and 120 grasp the needle10, the first and second electric contacts 156 and 160 contact theneedle 10, completing the electrical circuit 152 through the needle 10.The needle 10 acts as a resistive element in the electrical circuit 152and heats up upon completion of the electrical circuit 152 due to thecurrent flow through the needle 10. This heating melts, softens, orotherwise weakens the adhesive adhering the needle 10 to the needleholder 20, or if the needle 10 is embedded into the needle holder 20during molding without an adhesive, the heating melts, softens, orotherwise weakens the plastic of the needle holder 20 surrounding theneedle 10. Because of the melting, softening, or weakening, the biasingunit 112 displaces the receiving unit 108 upwardly (first direction),thereby displacing the needle holder 20 relative to the needle 10, whichtemporarily remains grasped by the first and second arms 116 and 120,and separating the entire needle 10 from the needle holder 20.

As the biasing unit 112 continues to displace the receiving unit 108 inthe first direction, the contact between the tapered portion 140 of theactivating unit 132 and the tapered portions 136 of the first and secondarms 116 and 120 decreases. Thus, after the needle 10 is separated fromthe needle holder 20, the first and second arms return to their initialspaced-apart positions and the needle 10 drops into the storage unit124. At this point, the user can recycle or dispose of the needle holder20 in the regular trash without any threat of needle-stick injury.

The device 100 depicted in FIGS. 1 and 2 illustrates the first andsecond electrical contacts 156 and 160 as being spaced apart from thejoint between the needle 10 and the needle holder 20 for clarity.Preferably, however, the first and second electrical contacts 156 and160 contact the needle 10 in close proximity to the joint between theneedle 10 and the needle holder 20, to minimize the amount of heatingnecessary to melt, soften, or weaken the glue joint and/or materialholding the needle 10 to the needle holder 20. Additionally, althoughfirst and second arms 116 and 120 are illustrated, one skilled in theart will appreciate that a greater number of arms or an arm and anvilconfiguration may be employed without departing from the scope of thepresent invention.

According to one embodiment, the device 100 is approximately the size ofa lipstick container. Additionally, according to one embodiment, thedevice 100 includes an indicator, such as an indicator light that alertsthe user when the storage unit 124 has reached a certain capacity.Further, according to one embodiment, the device 100 includes a similarfeature to manage power requirements, such as indicating the need forbattery replacement or recharging.

FIG. 3 is a cross-sectional schematic view of a needle removal andstorage device 170 in accordance with another embodiment of the presentinvention. The device 170 is substantially similar to the device 100shown in FIGS. 1 and 2, except that receiving unit 172, rather thanreceiving a hub of a pen needle, instead receives a hub or needle holder50 that, in conjunction with a needle 40, forms a syringe needle 60.

FIG. 4 is a cross-sectional schematic view of needle removal and storagedevice 180 in accordance with another embodiment of the presentinvention. In contrast to the embodiments of FIGS. 1-3, rather thanelectrical contacts, the device 180 includes a heating element 184. Theheating element 184 may be, for example, an appropriately selectedhigh-resistance nichrome wire 184. Moreover, rather than passing currentthrough the needle 10, the heating element 184 contacts and directlyheats the needle 10, thereby melting, softening, or otherwise weakeningthe glue or adhesive joint and/or material holding the needle 10 to theneedle holder 20.

The device 180 also includes separating means 182 that includes anelectrical circuit 188. The electrical circuit 188 includes a heatingelement 184 and a switch 192. According to one embodiment, afterdepressing the receiving unit 204 so that the first and second arms 208and 212 of the grasping unit 216 grasp the needle 10 and bring theheating element 184 into direct contact with the needle 10, the useractivates the switch 192 and completes the electrical circuit 188. Theuser activates the switch 192 by pressing a button 196, which is biasedupwardly by a second biasing unit 200, such as a leaf spring. Completingthe electrical circuit 188 passes current through the heating element184, thereby directly heating the needle 10 to melt, soften, or weakenthe adhesive joint and/or material holding the needle 10 to the needleholder 20.

In the embodiment shown in FIG. 4, a power source 220 is disposed withina housing 224 connected to the grasping unit 216. In addition, thedevice 180 includes a magnet 228 disposed within a storage unit 232.Once separated from the needle holder 20, the magnet 228 attracts theneedle 10 into the storage unit 232, and thus, the device 180 is notdependent upon gravity to move the needle 10 into the storage unit 232.One skilled in the art will appreciate that the receiving unit 204 maybe configured to receive a syringe needle or other medical needle ratherthan the pen needle depicted in FIG. 4 without departing from the scopeof the present invention.

FIG. 5 is a cross-sectional schematic view of needle removal and storagedevice 240 in accordance with another embodiment of the presentinvention. The device 240 is substantially similar to the device 100illustrated in FIGS. 1 and 2, except that the power source 244 isdisposed within the grasping unit 248, and the first and secondelectrical contacts 252 and 256 are respectively disposed on first andsecond arms 216 and 264 of the grasping unit 248. The device 240includes separating means 242 that includes an electrical circuit 246.One skilled in the art will appreciate that the receiving unit 268 maybe configured to receive a syringe needle or other medical needle ratherthan the pen needle depicted in FIG. 5 without parting from the scope ofthe present invention.

FIG. 6 is a cross-sectional schematic view of needle removal and storagedevice 270 in accordance with another embodiment of the presentinvention. In contrast to the previous embodiments, the device 270 isdirected to completely removing a needle from a needle holder in whichopposing ends of the needle are accessible. The receiving unit 272 andthe biasing unit 276 are substantially similar to those illustrated inFIGS. 1 and 2. In contrast, however, the grasping unit 280 includes afirst electrical contact 284 disposed on the first arm 286 and a firstelectrical coupler 290 disposed on an exterior surface of the graspingunit 280. In addition, the device 270 includes a cover or cap 292 thathas a second electrical contact 296, a power source 300, and a secondelectrical coupler 304.

In operation, as shown in FIG. 7, the user initially places the penneedle 30 in the receiving unit 272, and depresses the receiving unit272 until the first and second arms 286 and 288 grasp the needle 10 andthe first electrical contact 284 contacts a distal portion of the needle10. The user then connects the cover 292 with the grasping unit 280. Indoing so, the second electrical contact 296 contacts a proximal portionof the needle 10, and the second electrical coupler 304 couples with thefirst electrical coupler 291 thereby completing the electrical circuit308. Separating means 310 includes the electrical circuit 308.

When electrical circuit 308 is complete, current passes through theneedle 10. More particularly, in contrast to previously-describedembodiments, current passes through the portion of needle 10 where theadhesive adheres the needle 10 to the needle holder 20 and/or where thematerial holds the needle 10 to the needle holder 20. This providesresistive heating directly at the joint between the needle 10 and theneedle holder 20, whereas the previously-described embodiments rely onheat transfer axially along the needle to reach the joint. In otherwords, in the previously-described embodiments, electrical contacts orheating elements contact the needle in close proximity to the jointbetween the needle 10 and a needle holder 20, but even in theembodiments employing the electrical contacts, the current does not passthrough the needle at the joint. Instead, the current passing throughthe portion of the needle (or the heating element) heats the needle andthe heat transfers axially along the needle to the joint to melt,soften, or weaken the adhesive joint and/or material holding the needle10 to the needle holder 20. The device 270 shown in FIGS. 6 and 7,however, provides quicker heating of the joint, and therefore, quickerneedle removal.

According to one embodiment, the cover 292 is clear so that the user cansee when the needle 10 is removed from the needle holder 20. Accordingto another embodiment, the electrical circuit 308 includes an indicatorlight disposed on an exterior of the cover 292 that lights up when theelectrical circuit 308 is complete, and goes out when the electricalcircuit 308 is broken by first and second arms 286 and 288 moving apartand the needle 10 moving into the storage unit 312.

FIG. 8 is a cross-sectional schematic view of needle removal and storagedevice 320 in accordance with another embodiment of the presentinvention. Similar to the embodiments of FIGS. 6 and 7, in the device320, the grasping unit 324 includes a first electrical contact 328disposed on a first arm 332, and a first electrical coupler 336 disposedon an exterior of the grasping unit 324. The receiving unit 340,however, receives a needle holder 50 of a syringe needle 60.Additionally, the receiving unit 340 includes a second electricalcontact 344 biased radially away from a central axis of the receivingunit 340. Thus, when the syringe needle 60 is received centrally in thereceiving unit 340, the second electrical contact 344 is biased radiallyaway from the syringe needle 60.

According to one embodiment, the second electrical contact 344 is aspike 344 for cutting through the needle holder 50 to contact needle 40.Further, the spike 344 includes a plate 348 with a third electricalcontact 352 disposed on a radially outward side thereof. The spike 344is radially movable within a radial channel 356 of the receiving unit340, and the plate 348 is radially movable within a larger diameterradial channel 360 with a central axis coinciding with that of theradial channel 356. The plate 348 forms an angle with respect to thecentral axis of the radial channels 356 and 360. In addition, a secondbiasing unit 364 (for example, a spring 364) disposed within the largerdiameter radial channel 360, biases the plate 340 (and thus, the spike344) radially outward. The cover 368 includes a second electricalcoupler 372 electrically connected to a power source 376, which is inturn electrically connected to a fourth electrical contact 380 disposedon an internal protrusion 384 of the cover 368.

In operation, as shown in FIG. 9, the user initially places the syringeneedle 60 in the receiving unit 340, and depresses the receiving unit340 until the first and second arms 332 and 334 grasp the needle 40 andthe first electrical contact 328 contacts the needle 40. By thenconnecting the cover 368 with the grasping unit 324, the protrusion 384passes through an axial channel or slot 388 connected with the radialchannel 360 and drives the plate 348 and the spike 344 radially inwardto cut the needle holder 50 and contact the needle 40, and the fourthelectrical contact 380 contacts the third electrical contact 352. Thespike 344 contacts the needle 40 where the adhesive adheres the needle40 to the needle holder 50 and/or where the material holds the needle 40to the needle holder 50. Moreover, the second electrical coupler 372couples with the first electrical coupler 336, thereby completing theelectrical circuit 392 through the needle 40. Thus, the device 320 alsoheats and thereby melts, softens, or weakens the adhesive and/ormaterial at the joint between the needle 40 and the needle holder 50.Separating means 390 includes the electrical circuit 392.

Once the needle 40 moves into the storage unit 396, the user removes thecover 368, thereby breaking the electrical circuit 392. After removingthe cover 368, the spike 344 and the plate 348 move radially outwardunder the force from the second biasing unit 364, to disengage the spike344 from needle holder 50. At this point, the user can recycle ordispose of the needle holder 50 without the risk of needle-stick injury.

Like the cover 368, the cover 404 of another embodiment of needleremoval and storage device 400 shown in FIGS. 10-12 includes aprotrusion 408 and a power source 412 disposed on the cover 404. Inaddition, the receiving unit 416 includes an axial channel 420 in whichthe protrusion 408 travels and a plate 424 biased radially outward by asecond biasing unit 428. But rather than a spike, the receiving unit 416includes a heating element 432, for example, a nichrome wire 432, thatburns or melts through the needle holder 20 to contact the needle 10when connected to the power source 412.

To connect to the heating element 432 with the power source 412, theplate 424 has a pair of electrical contacts 436 electrically connectedto the heating element 432. The protrusion 408 has a corresponding pairof electrical contacts 440 connected to the power source 412. Inoperation, the user places the pen needle 30 in the receiving unit 416and depresses the receiving unit 416 until the first and second arms 444and 448 grasp the needle 10. Subsequently, during connection of thecover 404 with the grasping unit 452, the protrusion 408 passes throughthe axial channel 424 and contacts the plate 424, connecting therespective electrical contacts 436 and 440 and driving the plate 424radially inward in the radial channel 456. Driving the plate 424 throughthe radial channel 456 drives the heating element 432 through the radialchannel 460 to burn or melt through the needle holder and contact theneedle 10, to heat the needle 10 at the joint where the adhesive adheresthe needle 10 to the needle holder 20 and/or where the material holdsthe needle 10 to the needle holder 20.

Once the needle 10 moves into the storage unit 464, the user removes thecover 404, thereby breaking the electrical circuit 462. After removingthe cover 404, the heating element 432 and the plate 424 move radiallyoutward under the force from the second biasing unit 428, to disengagethe heating element 432 from needle holder 20. At this point, the usercan recycle or dispose of the needle holder 20 without the risk ofneedle-stick injury. Separating means 458 includes electrical circuit462.

As shown in FIG. 11, the heating element 432 includes a pair ofresistive heating elements 468 and 472 having respective resistances R1and R2. When connected, the electrical circuit 462 can be represented asshown in FIG. 12. In this state, the total resistance of electricalcircuit 462 is R1+R2.

Similar to the device 400, FIGS. 13-15 illustrate another embodiment ofa needle removal and storage device 480. In addition to a heatingelement 484 including first and second resistive heating elements 488and 492 the device 480 also has a first electrical contact 496 disposedon a first arm 500. Further, the grasping unit 508 includes a firstelectrical coupler 512 that is electrically connected to a power source516 as well as the first electrical contact 496.

A cover 520 includes a second electrical coupler 524 and a protrusion528 having second and third electrical contacts 532 and 536 disposedthereon. A receiving unit 540 includes a plate 544 is electricallyconnected to the heating element 484 and has fourth and fifth electricalcontacts 548 in 552 disposed thereon for connection with the second andthird electrical contacts 532 and 536, respectively.

In operation, as shown in FIG. 14, the user initially places the penneedle 30 in the receiving unit 540 and depresses the receiving unit 540until the first and second arms 500 and 504 grasp the needle 10 and thefirst electrical contact 496 contacts the needle 10. By then connectingthe cover 520 with the grasping unit 508, the protrusion 528 passesthrough the axial channel 556 in the receiving unit 540 and the secondand third electrical contacts 532 and 536 on the protrusion 528 contactthe fourth and fifth electrical contacts 548 and 552 on the plate 544,driving the plate 544 and the heating element 484 radially inward towardthe needle 10. In addition, the first and second electrical couplers 512and 524 couple together to complete the electrical circuit 560.Separating means 558 includes the electrical circuit 560.

In the state shown in FIG. 14, in which the heating element 488 hasburned or melted through the needle holder 20 to contact the needle 10,current flows not only through the heating element 484, but through theneedle 10 via the first electrical contact 496 disposed on the first arm500. The current flowing through both paths of the electrical circuit560 can be schematically represented as shown in FIG. 15. In this state,the total resistance of the electrical circuit 560 isR1+((R2*R3)/(R2+R3)). Thus, current flowing through both paths of theelectrical circuit 560 creates a lower resistance, resulting in a higherpower being dissipated, which results in rapid heating in the needle 10and melting, softening, or weakening of the adhesive joint where theadhesive adheres the needle 10 to the needle holder 20 and/or where thematerial holds the needle 10 to the needle holder 20.

Once the needle 10 moves into the storage unit 564, the user removes thecover 520, thereby breaking the electrical circuit 560. After removingthe cover 520 the heating element 484 and the plate 544 move radiallyoutward under the force from the second biasing unit 568, to disengagethe heating element 484 from needle holder 20. At this point, the usercan recycle or dispose of the needle holder 20 without the risk ofneedle-stick injury.

FIGS. 16 and 17 are cross-sectional schematic views of a needle removaland storage device 580 in accordance with another embodiment of thepresent invention. The device 580 includes the receiving unit 584receiving a pen needle 30, a first biasing unit 588, and grasping unit592 including first and second arms 596 and 598. The device 580 alsoincludes separating means 600 disposed on the first arm 596.

The separating means 600 includes an electrical circuit 604, a blademount 608 displaceably disposed on the first arm 596 and biased upwardly(first direction) by a second biasing unit 612, and a blade 616 mountedon the blade mount 608. The electrical circuit 604 includes a firstelectrical contact 620, a power source 624, and a second electricalcontact 628. The electrical circuit 604 also includes an electricalcontact plate 632 electrically connected to the blade 616 and mounted ona neck portion 636 of the blade mount 608.

The blade mount 608 includes the neck portion 636 connecting a lowerflange 640 and an upper mounting portion 644 on which the blade 616mounts. The first arm 596 includes a pocket 648 for displaceablyretaining the lower flange 640. In operation, as shown in FIG. 17, userinitially places the pen needle 30 in the receiving unit 584 and thendepresses the receiving unit 584 until the first and second arms 596 and598 grasp the needle 10 and the first electrical contact 620 contactsthe needle 10. This motion of the receiving unit 584 also brings theblade 616 into contact with the needle 10 and the needle holder 20,thereby depressing the blade mount 608 and sliding the electricalcontact plate 632 into contact with the second electrical contact 628 tocomplete the electrical circuit 604 through the needle 10.

In addition to cutting the needle holder 20, by being part of theelectrical circuit 604, the blade 616 also acts as a resistive heatingelement to melt or burn the needle holder 20. Thus, the cutting andmelting or burning by the blade 616, in combination with heating of theneedle 10 due to the current flow therethrough, provides for quickseparation of the needle 10 from the needle holder 20.

Although certain embodiments of FIGS. 1-17 are directed to removing aneedle from a pen needle holder, one skilled in the art will appreciatethat, generally, the concepts can also be implemented for syringes.Conversely, one skilled in the art will appreciate that thoseembodiments directed to removing a needle from a syringe needle holdercan also be implemented for pen needles.

FIG. 18 is a perspective view of a bead-needle assembly 660 for a peninjection device in accordance with an embodiment of the presentinvention. The bead-needle assembly 660 includes a needle 664 and a bead668. According to one embodiment, the needle 664 is a standard penneedle cannula and the bead 668 is made of a soft rubber-like material,for example, a liquid silicone rubber (LSR) or thermo-plastic elastomer(TPE). According to one embodiment, the bead 668 is molded onto theneedle 664. The reason for the bead 668 being made of a rubber-likematerial is to easily remove/cut away the bead 668 from the needle 664after use.

FIGS. 19-21 illustrate alternative beads that could be employed with theneedle 664. In FIG. 19, the bead 672 is substantially cylindrical andhas a central bore 676 therethrough for accommodating the needle 664.Additionally, the bead 672 is perforated 680. The bead 684 in FIG. 20includes an outer cylinder 688 connected by radial spoke arms 690 withan inner cylinder 692 having a central bore 696 therethrough foraccommodating the needle 664. As shown in FIG. 21, the bead 700 includesa cylinder 704 with an internally extending radial spoke arms 708 thatmeet centrally within the cylinder 704 to accommodate the needle 664.

FIG. 22 is a perspective view of a carrier 712 for a plurality ofbead-needle assemblies 660. As shown in FIG. 22, the bead-needleassemblies 660 can be packaged in a honeycomb-like matrix package 712.This type of packaging is efficient in terms of packing density and interms of the amount of plastic required to manufacture the carrier 712.After insertion of a bead-needle assembly 660 into each of the cells 716of the carrier 712, removable sealing tabs or labels 720 secure thecells 716 and maintain the sterility of the bead-needle assemblies 660prior to use.

To connect the bead-needle assembly 660 with a pen injection device, asshown in FIGS. 23 and 24, an adapter 724 threaded for connection with apen injection device selectively secures the bead needle assembly 660.The adapter 724 includes a threaded portion 728 for connection with athreaded end of a pen injection device. Additionally, the adapter 724includes a plurality of cantilevered arms 732 with hooks 736 disposed offree ends thereof. To mount the bead-needle assembly 660 in the adapter724 the user first threads the adapter onto the pen injection device. InFIG. 24, however, the injection device is omitted for clarity.Subsequently, the user axially aligns the adapter 724 and bead-needleassembly 660 and presses the adapter 724 over the bead-assembly. Cantedfaces of the hooks 736 contact the bead 672 and displace the ends of thecantilevered arms 732 outwardly, permitting the cantilevered arms toslide over the bead 672. Once the hooks 736 pass a distal end of thebead 672, as shown in FIG. 24, the cantilevered arms 732 snap back totheir original position and the hooks 736 secure the bead-needleassembly 660 within the adapter 724.

FIG. 25 is a partial perspective view of a cutting unit 740 and FIG. 26is a partial perspective view of a needle removal and storage device 750employing the cutting unit 740 in accordance with another embodiment ofthe present invention. Separating means 738 includes the cutting unit740. The cutting unit 740 includes a base 744 with a plurality ofcantilevered arms 746, each having a blade 748 disposed at free endthereof. The cantilevered arms 746 are circumferentially spaced aroundthe base 744 to accommodate the cantilevered arms 732 of the adapter 724therebetween. As shown in FIG. 26, a proximal end of a receiving unit752 includes a cage 756 for securely holding the cutting unit 740.According to one embodiment, the cage 756 is configured to selectivelyhold the cutting unit 740, so that the cutting unit 740 can be replacedwhen the blades 748 become dull.

In operation, the user aligns the cantilevered arms 732 of the adapter724 between the cantilevered arms 746 of the cutting unit 740 andpresses the pen injection device downward (second direction), therebydisplacing the receiving unit 752 downward until the arms 760 of thegrasping unit 764 grasp the needle 664. During this motion, the blades748 of the cutting unit 740 slice the bead 672 and separate the bead 672from the needle 664. As the user withdraws the pen injection device, abiasing unit 768 displaces the receiving unit 752 upward (firstdirection) permitting the arms 760 to move back to their initialposition and permitting the needle 664 to fall into the storage unit772. At this point, the user can remove the cut pieces of the bead 672from the adapter 724 and recycle or dispose of the cut pieces withoutthe risk of needle-stick injury.

FIGS. 27 and 28 are perspective views of opposing ends of a carrier andneedle removal and storage device 780 in accordance with anotherembodiment of the present invention. As shown in FIG. 27, the device 780has a central opening 784 in a first end thereof providing access to aneedle removal and storage device, such as the device 750. The opposingend of the device 780, as shown in FIG. 28, includes cells 788 forstoring bead-needle assemblies 660. Removable sealing tabs or labels 792secure the cells 788 and maintain the sterility of the bead-needleassemblies 660 prior to use.

FIG. 29 is a perspective view of a carrier and needle removal andstorage device 800 in accordance with another embodiment of the presentinvention. The device 800 includes a carrier 804 having cells 808 forstoring bead-needle assemblies 660. Removable sealing tabs or labels 812secure the cells 808 and maintain sterility of the bead-needleassemblies 660 prior to use. Additionally, the carrier 804 has a centralopening 816 with grooves 820 extending radially outward therefrom.

According to one embodiment, the storage unit, such as storage unit 772of the device 750 can hold the significant number of separated needles664. More specifically, the storage unit 772 can hold more needles 664than the carrier 804 can carry. Accordingly, the device 800 includes aseparable needle removal and storage device holder 824 that has a needleremoval and storage device, such as device 750 disposed therein. Theholder 824 has axial fins 828 corresponding to the grooves 820 toselectively secure the holder 824 within the central opening 816 of thecarrier 804. After using all of the bead-needle assemblies 660 in thecarrier 804, the user can remove the holder 824 from the carrier 804 andinstall the holder 824 into a new carrier 804 with unused bead-needleassemblies 660.

Although the embodiments of FIGS. 18-29 are directed to a fundamentallydifferent needle assembly for pen injection devices, one skilled in theart will appreciate that the concept can also be implemented forsyringes.

FIG. 30 is a cross-sectional schematic view of a sharps container or box832 with needle removal and storage devices in accordance withembodiments of the present invention disposed thereon. For example, asshown in FIG. 30, the sharps box 832 includes a pen needle device 836, asyringe needle device 840, and a bead-needle device 844. Further, thesharps box 832 includes a common storage unit 848 that stores needlesfrom all three devices 836, 840, and 844. This box-like needle removerand containment device may be utilized, for example, in ambulances orstationary locations, such as clinics or hospitals.

FIG. 31 is a perspective view of a case 852 having a needle removal andstorage device in accordance with an embodiment of the present inventiondisposed therein. A user inserts the needle into a port 856 on a side ofthe case 852 to access the needle removal and storage device. The case852 provides a slim, portable unit for the convenience of a user.

FIG. 32 is a perspective view of a pen needle dispenser 860 with aneedle removal and storage device 870 in accordance with an embodimentof the present invention disposed thereon. The dispenser 860 includes acover 864 at a first end, a plurality of pen needles 866 disposedtherein, and an advancing unit 868 for advancing the pen needles 866toward the first end. The device 870 is disposed at a second end of thedispenser 860 for the convenience of a user.

FIG. 33 is a perspective view of another pen needle dispenser 900 with aneedle removal and storage device 904 in accordance with an embodimentof the present invention disposed thereon. According to one embodiment,the dispenser 900 has a short cylindrical body 908 and the device 904 isdisposed centrally within the body 908. One skilled in the art willappreciate, however, that other shapes and other positions for thedevice 904 may be employed without departing from the scope of thepresent invention. The dispenser 900 has a plurality of cells 912 forholding a corresponding plurality of pen needles 30. Each cell 912 has alid or cover 916 for sealing the cell 912.

According to one embodiment, a user opens a lid 916 to expose a penneedle 30 within a cell or cavity 912. The pen needle 30 may be encasedin a plastic case with a sterile paper cover 920 or may have a sterilepaper cover 920 attached directly thereto. The user removes the penneedle 30 from the body 908 (for example, by turning over the dispenser900), removes the sterile cover 920, and attaches the pen needle 30 to apen injection device. Subsequent to injection, the user presses the peninjection device with the needle 30 attached thereto into the device904, which removes the needle 10 from the needle holder 20. The user canthen recycle or dispose of the needle holder 20 without risk ofneedle-stick injury. Alternatively, the user can replace the needleholder 20 in the cell 912 and close the lid 916 to recycle or dispose ofthe needle holder 20 at a more convenient time. In such an embodiment,the user can restock the cells 912 with unused pen needles 30.

FIG. 34 is a perspective view of another pen needle dispenser 950 with aneedle removal and storage device 952 in accordance with an embodimentof the present invention disposed thereon. According to one embodiment,the dispenser 950 includes a pen needle dispenser as disclosed in U.S.Pat. No. 5,873,462 to Nguyen et al., hereby incorporated by reference inits entirety. Similar to the device 900, the dispenser 950 has a shortcylindrical body 956 and the device 952 is disposed centrally within thebody 956. One skilled in the art will appreciate, however, that othershapes and other positions for the device 952 may be employed withoutdeparting from the scope of the present invention. The dispenser 950 hasa plurality of cells or cavities 960 for holding a correspondingplurality of pen needles 30.

In contrast to the dispenser 900, however, rather than lids for eachcell 960, the dispenser 950 includes a rotatable cover 964 (showndisconnected from the body 956 in FIG. 34 for clarity). The cover 964includes a central opening 966 for accessing the device 952 and aselecting opening or slot 968 to selectively align with a cell 960 todispense a pen needle 30 therefrom. According to one embodiment, thebody 956 also has a blank space 972 for alignment with the selectingopening 968 during transport, to maintain the pen needles 30 within thedispenser 950.

In use, a user rotates the cover 964 to align the selecting opening 968with a selected one of the cells 960 and removes a pen needle 30 (forexample, by turning over the dispenser 950), removes the sterile cover976, and attaches the pen needle 30 to a pen injection device.Subsequent to injection, the user presses the pen injection device withthe needle 30 attached thereto into the device 952, which removes theneedle 10 from the needle holder 20. The user can then recycle ordispose of the needle holder 20 without risk of needle-stick injury.

According to another embodiment, the user can replace the needle holder20 in the cell 960 and rotate the cover 964 to recycle or dispose of theneedle holder 20 at a more convenient time. According to anotherembodiment, the user can restock the cells 960 with unused pen needles30. Embodiments of the present invention may be used to provideportable, personal sharps containers that allow for safe disposal ofcontaminated sharps and may improve needle disposal compliance of needleusers. In addition, embodiments of the present invention entirely removethe sharps portion of an injection device and retain the needle inside,while allowing the user to recycle or discard the plastic non-sharpscomponent as regular trash. Further, with embodiments of the presentinvention, users do not need to replace their sharps containersfrequently due to the low volume occupied per needle. Additionally,storage units themselves may be made significantly smaller than priorart sharps containers, thus making them more convenient and portable.This convenience may result in increased sharps disposal compliance.Moreover, complicated electronics are not required. Readily availablepower sources, such as AA or 9V batteries, or button cell batteries canbe used for personal, portable needle removable storage devices inaccordance with embodiments of the present invention.

Although only a few exemplary embodiments of the present invention havebeen described in detail above, those skilled in the art will readilyappreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of the appended claims andequivalents thereof.

1. An apparatus for removing a needle from a needle holder, comprising:a grasping unit for selectively grasping the needle; a receiving unitfor receiving the needle holder, displaceably disposed relative to thegrasping unit; a biasing member biasing the receiving unit in a firstdirection; separating means for separating the entire needle from theneedle holder.
 2. The apparatus according to claim 1, wherein thegrasping unit includes a chamber for receiving a needle separated fromits holder.
 3. The apparatus according to claim 1, wherein the receivingunit comprises an activating unit for automatically causing arms of thegrasping unit to grasp a needle upon displacement of the receiving unitin a second direction opposite to the first direction.
 4. The apparatusaccording to claim 1, wherein the arms of the grasping unit are tapered;and wherein the activating unit comprises an annular disk.
 5. Theapparatus according to claim 1, wherein the separating means heats theneedle to melt, soften, or otherwise weaken material and/or adhesiveconnecting the needle with the needle holder.
 6. The apparatus accordingto claim 5, wherein the receiving unit comprises an activating unit forautomatically causing arms of the grasping unit to grasp the needle upondisplacement of the receiving unit in a second direction opposite to thefirst direction; wherein the separating means comprises an electricalcircuit completed by the needle; and wherein current flowing through theelectrical circuit melts, softens, or otherwise weakens the materialand/or adhesive connecting the needle with the needle holder, allowingthe receiving unit to displace in the first direction under the bias ofthe spring while arms of the grasping unit grasp the needle, to separatethe needle from the needle holder.
 7. The apparatus according to claim6, wherein a pair of electrical contacts are respectively disposed on apair of the arms of the grasping unit, and wherein the needle completesthe electrical circuit when grasped by the arms.
 8. The apparatusaccording to claim 6, further comprising a cover selectively connectableto the grasping unit, the cover having a first electrical contact;wherein one of the arms has a second electrical contact disposedthereon; and wherein subsequent to displacing the receiving unit in thesecond direction, causing the arms of the grasping unit to grasp asecond end of the needle, upon connecting the cover to the graspingunit, the first electrical contact contacts a first end of the needleand completes the electrical circuit through the needle.
 9. Theapparatus according to claim 6, further comprising a cover selectivelyconnectable to the grasping unit, the cover having an internalprotrusion; wherein one of the arms has a first electrical contactdisposed thereon; wherein the receiving unit comprises a secondelectrical contact biased away from the needle and selectivelydisplaceable through the receiving unit; and wherein subsequent todisplacing the receiving unit in the second direction, causing the armsof the grasping unit to grasp the needle, upon connecting the cover tothe grasping unit, the protrusion displaces the second electricalcontact to contact the needle, completing the electrical circuit throughthe needle.
 10. The apparatus according to claim 9, wherein the secondelectrical contact comprises a spike that cuts through the needle holderto contact the needle.
 11. The apparatus according to claim 9, whereinthe second electrical contact comprises a resistive heating element thatburns or melts through the needle holder to contact the needle.
 12. Theapparatus according to claim 11, wherein the resistive heating elementcomprises a nichrome wire.
 13. The apparatus according to claim 11,further comprising a third electrical contact disposed on the receivingunit for contacting the needle and providing an additional current paththrough the needle.
 14. The apparatus according to claim 6, wherein thegrasping unit further comprises a resistive heating element comprising ablade simultaneously contacting the needle to complete the electricalcircuit through the needle and cutting and melting or burning throughthe needle holder.
 15. The apparatus according to claim 1, wherein thereceiving unit comprises an activating unit for automatically causingarms of the grasping unit to grasp the needle upon displacement of thereceiving unit in a second direction opposite to the first direction;wherein the needle holder comprises a bead adhered to the needle;wherein a pen injector for selective connection with the needle-beadassembly includes an adaptor for connecting the needle-bead assemblythereto; and wherein the separating means comprises blades disposed oncantilevered arms for cutting the bead upon displacement of thereceiving unit in the second direction, the cantilevered arms beingdisposed on the receiving unit.
 16. The apparatus according to claim 15,wherein the bead is perforated.
 17. The apparatus according to claim 15,wherein the bead comprises a cylinder for holding the needle connectedby radial spoke arms to an outer cylinder.
 18. The apparatus accordingto claim 15, wherein the bead comprises a cylinder with internallyextending radial spoke arms that hold the needle.
 19. The apparatusaccording to claim 1, further comprising a needle dispenser integratedwith the apparatus.
 20. A method of separating a needle from a needleholder, comprising: receiving the needle holder in a receiving unitbiased in a first direction; displacing the receiving unit relative to agrasping unit in a second direction opposite to the first direction,thereby automatically causing the grasping unit to grasp the needle andactivating a separator for separating the needle from the needle holder;and maintaining the grasp of the needle until the separator separatesthe entire needle from the needle holder.
 21. The method according toclaim 20, wherein activating the separator comprises completing anelectrical circuit through the needle.
 22. The method according to claim20, wherein activating the separator comprises cutting the needleholder.
 23. An apparatus for removing a needle from a needle holder,comprising: a grasping unit for selectively grasping the needle; areceiving unit for receiving the needle holder, displaceably disposedrelative to the grasping unit; a biasing member biasing the receivingunit in a first direction; a separator for separating the entire needlefrom the needle holder; and a storage unit for storing the separatedneedle.
 24. A method of separating a needle adhered to and/or molded ina needle holder, comprising: heating the needle to melt, soften, orotherwise weaken a material and/or adhesive connecting the needle withthe needle holder; and separating the entire needle from the needleholder.
 25. The method according to claim 24, wherein the heatingcomprises electrically heating the needle to melt, soften, or otherwiseweaken the material and/or adhesive connecting the needle with theneedle holder.
 26. The method according to claim 25, wherein the heatingcomprises completing an electrical circuit through the needle andpassing current through the needle.
 27. The method according to claim26, wherein the current passes through a portion of the needle where theneedle is connected to the needle holder.
 28. The method according toclaim 26, wherein the current passes through a portion of the needleother than a portion of the needle where the needle is connected to theneedle holder, and heat is conducted to the portion of the needle wherethe needle is connected to the needle holder.
 29. The method accordingto claim 25, wherein the heating comprises passing current through aheating element.
 30. The method according to claim 24, furthercomprising disposing of the separated needle.
 31. The method accordingto claim 24, further comprising disposing of the needle holder.